Sun Pharmaceutical, which is one of the largest purveyors of generic drugs, allegedly falsified various documents that were maintained by employees at one of its plants in India, according to an inspection report issued by the U.S. Food and Drug Administration.
During a visit earlier this month to a plant in Mohali, FDA inspectors examined records pertaining to discrepancies in a batch of medicines and found records were allegedly backdated by quality assurance and quality control employees. However, the agency was unable to determine the extent to which documents were backdated or thoroughly evaluate all of the allegations.
Nonetheless, the FDA report noted that a two-day corporate quality audit to assess the risk that backdating could occur did identify examples in which “non-contemporaneous” documentation took place. But the audit did not include specific actions that would further identify whether backdating was still occurring or the extent of previous backdating, according to the agency report.
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